There’s a quotidian calculation to outsourcing at Allena Pharmaceuticals that's well worth studying.
“As a small biotech, we could get kicked to the curb because somebody else has more dollars, and can occupy longer those assets at a CMO that we need. Because of this, we’ve evolved a concept of portability for our manufacturing process that may be anathema to a lot of companies …"
Analytical instrument can provide a high level of confidence in the integrity and quality of the manufactured product through scientific data, and that confidence can only be achieved through proper instrument qualification
According to the latest PharmSource Trend Report, "Bio/Pharma CapEx Trends 2016", biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises
Formulation scientistsmust develop and validat robust systems that address the challenges posed by increasingly complex drug candidates, in ever shortening time frames.
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.
Because of the numerous challenges involved in the roller compaction of low dose active pharmaceutical ingredients, Patheon, Inc. recently conducted a study to determine the optimal design space and scale up conditions for such an application. They also set out to minimize the amount of active pharmaceutical ingredients needed in the early stages of drug development in order to save on costs and overcome short supply issues that are typical during the earlier stages of drug development. Read on to learn what they found out.
This application note focuses on microfiltration (pore sizes between 0.1 µm and 1 µm). Microfiltration is ideally suited for separation of cultured cells from the growth medium (broth), as well as for sterilization, and contaminant and particle removal in numerous biopharmaceutical processes
The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.
In this case study, we compare production capacity and process economy between stainless steel and single-use equipment in microbial processes. Economy simulations were based on an E. coli Dab process. Production scenarios in both single- and multi-product facilities were considered.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
This article explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.
The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.